Update: FDA Requires Boxed Warning on Amputation Risk with Invokamet

May 16, 2017 – Based on the final results of 2 long-term clinical trials, FDA has concluded that type 2 diabetes patients who take Invokana or Invokamet are twice as likely to have their foot or toe amputated. As a result of these findings, the agency is requiring that both medications carry a boxed warning regarding the amputation risk.

What is Invokamet?

Invokamet contains canagliflozin and metformin, oral diabetes medications that help control blood sugar levels. Canagliflozin works by helping the kidneys remove glucose from the blood. Metformin lowers glucose production in the liver and also causes the intestines to absorb less glucose. Invokamet is made by Janssen Pharmaceuticals (a Johnson & Johnson company), and was approved by the U.S. Food & Drug Administration (FDA) in August 2014.

FDA Issues Warning on New Diabetes Medications

According to an FDA warning issued May 15, 2015, Invokamet and other diabetes medications from the SGLT2 inhibitor class have been linked to an increased risk of ketoacidosis. Examining the FDA Adverse Event Reporting System (FAERS), at least 20 cases of “diabetic ketoacidosis,” “ketoacidosis,” or “ketosis” were observed in patients treated with SGLT2 inhibitors from March 2013 to June 2014.

Ketoacidosis Symptoms

Signs of ketoacidosis often develop quickly, sometimes within 24 hours or less. In some patients, the following symptoms may be the first sign of having diabetes:

  • Excessive thirst
  • Frequent urination
  • Nausea and vomiting
  • Abdominal pain
  • Weakness or fatigue
  • Shortness of breath
  • Fruity-scented breath
  • Confusion

More specific signs of ketoacidosis — which can be detected through blood or urine testing kits — include:

  • High blood sugar level (hyperglycemia)
  • High ketone levels in the urine

SGLT2 Inhibitor Drug List

In addition to Invokamet, other type 2 diabetes medications from the SGLT2 inhibitor class include:

Why This Matters

According to the Centers for Disease Control and Prevention (CDC), there are nearly 30 million people with diabetes in the U.S. today. Since less than 10% of all diabetes cases are found to be the genetically inherited type 1 form of the disease, this means there are 26 to 27 million Americans with type 2 diabetics. Therefore, the recent FDA warning is significant to a large number of people.

Invokamet Side Effects

  • Diabetic Ketoacidosis, DKA, Diabetic Acidosis, Ketoacidosis, Metabolic Acidosis
  • Heart Attack
  • Amputations of the Leg, Foot and Toes
  • Kidney Failure (Renal Failure)
  • Kidney Cancer
  • Kidney Infections (Pyelonephritis)
  • Kidney Stones
  • Bone Fractures
  • Bone Abnormalities
  • Stroke
  • Testicular Cancer
  • Urinary Tract Infections (UTIs)
  • Severe Dehydration / Fluid Imbalance
  • Lactic Acidosis
  • Abnormal Weight Loss
  • Hypersensitivity (Allergic Response)
  • Blood Infections (Urosepsis)
  • Fungal Infections

Court Establishes ‘Benefit and Expenses Fund’ for Invokana MDL

March 30, 2017 – A Common Benefit Fee and Expense Fund has been established in the Invokana MDL “to provide for the fair and equitable sharing among plaintiffs and their counsel” for expenses incurred during the litigation process. The funds apply to all Invokana and Invokamet lawsuits pending in MDL No. 2750, according to a Pretrial Order issued last week.

Invokamet Lawsuits Consolidated in New Jersey

December 19, 2016 – The U.S. Judicial Panel on Multidistrict Litigation (JPML) has ordered that all federal lawsuits alleging kidney failure and diabetic ketoacidosis from Invokana and Invokamet will be transferred to the District of New Jersey for pretrial handling before Judge Brian R. Martinotti. J&J and Janssen currently face about 55 such complaints in courts across the U.S. However, it is expected that this number will grow into the hundreds or even thousands by the time the litigation process is complete.

FDA Upgrades Kidney Injury Warning on SGLT2 Inhibitors

June 14, 2016 – Type 2 diabetes patients who take canagliflozin (Invokana, Invokamet) or dapagliflozin (Farxiga, Xigduo XR) may have an increased risk of suffering an acute kidney injury, according to an FDA drug safety communication issued today. The agency strengthened warnings on the medications after receiving at least 101 confirmable cases of acute kidney injury in SGLT2 inhibitor users from March 2013 to October 2015.

FDA Approves Expanded Use of Invokamet

May 24, 2016 – Janssen announced today that the FDA has approved Invokamet as a first-line treatment for adults with type 2 diabetes, according to Seeking Alpha. Previously, Invokamet was only approved for use in type 2 diabetics whose symptoms were not adequately controlled with metformin or canagliflozin, or who were already being treated with both these medications.

FDA Warns About Amputation Risk with Invokamet

May 18, 2016 – The latest in a string of serious side effects linked to Invokamet is leg and foot amputations, according to an FDA warning issued today. Interim data from an ongoing clinical trial found a higher incidence of amputations in patients treated with canagliflozin — the active ingredient in Invokamet — requiring leg, foot or toe amputations twice as often as those treated with a placebo.

Invokamet Bone Fracture Warnings Strengthened

September 10, 2015 – FDA has strengthened warnings for the diabetes medication canagliflozin (Invokamet, Invokana) regarding an increased risk of bone fractures and decreased bone mineral density, according to a Drug Safety Communication issued today. To address these concerns, FDA has added a new “Warning and Precautions” section and revised the “Adverse Reactions” section of canagliflozin drug labels.

Has There Been a Recall?

To date, Invokamet has not been recalled in the U.S. or any other country. However, the drug does contain a black box warning regarding lactic acidosis, a condition that results from a buildup of lactic acid. Patients who suspect lactic acidosis should go to a hospital immediately.

Do I Have an Invokamet Class Action Lawsuit?

The Pharmaceutical Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in Invokamet lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.

Free Confidential Case Evaluation: Again, if you or a loved one has been injured by the side effects of Invokamet, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.

FREE Confidential Case Evaluation

To contact us for a free review of your potential case, please fill out the form below or call us toll free 24 hrs/day by dialing: (866) 223-3784.

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